Prospective Randomized Controlled Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Complication rate after using omental roll-up technique
研究概览
简要总结
Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue.
Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.
详细描述
This is a RCT study designed to compare the use of omental roll-up technique with non-omental roll-up technique at pancreato-jejunal anastomosis in patients undergoing pancreatoduodenectomy. The purpose of this study is to prove the hypothesis that omental roll-up technique can reduce the complication rate or pancratic fistula after pancreatoduodenectomy. This study was approved by the committee on human rights to conduct the research involving human subjects, faculty of medicine Ramathibodi hospital, Mahidol university. The patients are operated by experienced surgeons of Hepato-pancreato-biliary unit, department of surgery, Ramathibodi hospital and randomized into two groups by using the closed envelope method after completing pancreato-jejunal anastomosis. Then, patients are followed-up and the data are collected for 30 days after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing pancreatoduodenectomy from these disease, carcinoma at head of pancreas, carcinoma at ampullar of Vater, Distal cholangiocarcinoma, Carcinoma of duodenum
排除标准
- •Unresectable pancreatoduodenectomy
- •Patients underwent omentectomy from prior surgery
研究组 & 干预措施
Omental Roll-up
干预措施: Omental Roll-up (Procedure)
No Omental Roll-up
结局指标
主要结局
Complication rate after using omental roll-up technique
时间窗: Within 30 days after surgery
Complication rate after using omental roll-up technique compare with non-omental roll-up
次要结局
- Pancreatic fistula rate after using omental roll-up technique(Within 30 days after surgery)
研究者
Paramin Muangkaew, MD
Principal Investigator
Mahidol University
